To investigate the safety of the of bone marrow-derived human multipotent mesenchymal stromal cells (MMSCs) administration in neutropenic patients with septic shock.
A single center prospective randomized Russian clinical trial of MMSCs in neutropenic patients with septic shock was registered (RUMСESS) (NCT 01849237). The patients were randomly assigned to receive conventional therapy (CT) (n = 15) or intravenous MMSCs + CT (n = 15) at the dose of 1 × 106 MMSCs/kg.
Initial SOFA scores were 15.9 (95% CI 13.9-20.2) in MMSCs + CT and 16.1 (95% CI 12.1-19.0) in CT group. For second day cardiovascular component of SOFA and PaO2/FiO2 improved in MMSC + CT group. 28-days survival rates were 20% (3/15 patients) in CT group and 60% (9/15 patients) in the MMSC + CT group (P < 0.05). In MMSC + CT group only 4 patients remained alive in 3 months, 5 patients died due to the infection related organ dysfunctions, in CT group 3 patients remained alive in 3 months.
Administration of MMSCs in neutropenic patients with septic shock was well tolerated and attributed to the faster hemodynamic stabilization, vasopressor withdrawal, attenuation of respiratory failure and shortening of the neutropenia duration period.